erlotinib in treating patients with locally advanced and/or metastatic endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. purpose: phase ii trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.

objectives: * determine the efficacy of erlotinib, in terms of response rate and duration of stable disease, in patients with locally advanced and/or metastatic carcinoma of the endometrium. * determine the toxicity of this drug in these patients. * determine the time to progression and duration of response in patients treated with this drug. * correlate objective tumor response with levels of epidermal growth factor receptor expression in patients treated with this drug. outline: this is a multicenter study. patients receive oral erlotinib once daily. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed at 4 weeks. patients with complete or partial response or stable disease are also followed every 3 months until relapse or death. projected accrual: a total of 15-30 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic and/or locally advanced adenocarcinoma or adenosquamous carcinoma of the endometrium * incurable by standard therapies * clinically and/or radiologically documented disease with at least 1 unidimensionally measurable site * at least 20 mm by x-ray, physical exam, or ct scan or * at least 10 mm by spiral ct scan * bone metastases considered nonmeasurable * tumor tissue from primary tumor available for assessing epidermal growth factor receptor (egfr) status * no uterine sarcomas (leiomyosarcoma), mixed mullerian tumors, and/or adenosarcomas * no known brain metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * platelet count at least 100,000/mm3 * absolute granulocyte count at least 1,500/mm3 hepatic: * bilirubin no greater than upper limit of normal (uln) * ast/alt no greater than 2.5 times uln renal: * creatinine no greater than 1.5 times uln cardiovascular: * no symptomatic congestive heart failure * no unstable angina * no cardiac arrhythmia gastrointestinal: * no gastrointestinal (gi) tract disease that would preclude ability to take oral medication * no requirement for iv alimentation * no uncontrolled inflammatory gi disease (e.g., crohn's disease or ulcerative colitis) * no active peptic ulcer disease ophthalmic: * no significant ophthalmologic abnormalities, including any of the following: * prior severe dry eye syndrome, sjogren's syndrome, or keratoconjunctivitis sicca * severe-exposure keratopathy * disorders that would increase the risk of epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) * congenital abnormality (e.g., fuch's dystrophy) * abnormal slit-lamp examination using a vital dye (e.g., fluorescein or bengal-rose) * abnormal corneal sensitivity test (e.g., schirmer test or similar tear production test) * no concurrent ocular inflammation or infection other: * no other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * no prior allergic reaction attributed to compounds of similar biological or chemical composition to erlotinib * no other concurrent serious illness or medical condition that would preclude study * no prior significant neurologic or psychiatric disorder that would preclude study * no active uncontrolled infection * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy for endometrial cancer endocrine therapy: * no more than 1 prior hormonal therapy (progestational agent or aromatase inhibitor) in the adjuvant or metastatic setting * at least 1 week since prior hormonal therapy radiotherapy: * at least 4 weeks since prior radiotherapy (except for low-dose palliative radiotherapy) and recovered surgery: * at least 3 weeks since prior major surgery and recovered * no prior surgical procedures affecting absorption * no concurrent ophthalmic surgery other: * no prior egfr-targeting therapies * no other concurrent investigational therapy * no other concurrent anticancer therapy * concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance with respect to monitoring inr * concurrent low molecular weight heparin allowed at investigator's discretion

Keywords: stage iv endometrial carcinoma recurrent endometrial carcinoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma